FDA product code NQI: System, Immunomagnetic, Circulating Cancer Cell, Enumeration
NQI is the FDA product code for system, immunomagnetic, circulating cancer cell, enumeration. It is a Class II device, regulated under 21 CFR 866.6020 and reviewed by the Pathology panel. FDA has cleared 12 510(k) submissions under NQI, from 2 different applicants. The average 510(k) review took 100 days (median 84). 1 De Novo request was granted under it. FDA has posted 9 recalls for NQI devices, 1 initiated in the last five years.
Definition
In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.
Classification
| Field | Value |
|---|---|
| Device name | System, Immunomagnetic, Circulating Cancer Cell, Enumeration |
| Device class | Class II |
| Regulation | 21 CFR 866.6020 |
| Review panel | PA — Pathology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every NQI clearance
Top NQI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Veridex, LLC | 10 | 2013-06-20 |
| Immunicon Corp. | 2 | 2006-03-16 |
Most recent NQI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K130794 | Veridex, LLC | CELLTRACKS ANALYZER II SYSTEM | 2013-06-20 | 90 |
| K122821 | Veridex, LLC | CELLTRACKS AUTOPREP SYSTEM | 2012-12-13 | 90 |
| K110406 | Veridex, LLC | CELLTRACKS AUTOPREP SYSTEM | 2012-01-20 | 340 |
| K113181 | Veridex, LLC | CELLTRACKS ANALYER II | 2011-12-12 | 45 |
| K103502 | Veridex, LLC | CELLSEARCH CIRCULATING TUMOR CELL KIT MODEL 7900001 | 2010-12-21 | 22 |
Recalls for NQI devices
9 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2022-05-20.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2022 | 1 |
Frequently asked questions
What is FDA product code NQI?
NQI is the FDA product code for system, immunomagnetic, circulating cancer cell, enumeration. It is a Class II device, regulated under 21 CFR 866.6020 and reviewed by the Pathology panel.
What device class is NQI?
Class II, regulation 21 CFR 866.6020. Typical premarket route: 510(k).
How long does a 510(k) take for product code NQI?
Across 12 cleared submissions the average was 100 days from receipt to decision (median 84).
Which companies have the most NQI clearances?
Veridex, LLC (10); Immunicon Corp. (2).
Have NQI devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2022-05-20.
Next steps
- Run an FDA pathway report with predicate devices for product code NQI
- Run a recall and safety report across every NQI manufacturer
- Watch product code NQI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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